INSTAFLEX PAIN RELIEF CREAM- menthol cream 
Adaptive Health, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Instaflex Pain Relief Cream

Drug Facts 

Active Ingredient

Menthol (1.25%)

Purpose

Topical Analgesic 

Uses Temporarily relieves minor aches and pains

of muscles and joints associated with: 

Warnings

For external use only

Do not use

  • with a heating pad, may blister skin
  • on open wounds or damaged skin 

Ask a doctor before use if you have

redness over the affected area

When using this product

  • Use only as directed 
  • avoid contact with eyes 
  • do not bandage tightly

Stop use and ask a doctor if

  • skin redness or excessive skin irritation develops
  • condition worsens or symptoms persist for more than 7 days 
  • symptoms clear up and occur again in a few days 

Keep out of reach of children. 

If swallowed, get medical help or contact a Poison Control Center right away. 

Directions Adults and children 12 years of

age and older: Apply to affected area no more than

3-4 times daily. Children under 12 years of age:

Consult a doctor. 

Other information 

Keep product at room termperature and

humidity [59-86°F (15-30°C), 40% RH]. Do not freeze. For Lot

Number and Expiration Date, see crimp at end of tube. 

Inactive ingredients C13-14 Isoparaffin, Citrus Aurantium

Dulcis (Orange) Oil, Ethylhexlglycerin, Eucalyptus Globulus Oil,

Glyceryl Stearate, Laureth-7, Oxygenated Corn Oil, PEG-100

Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Water 

PAIN RELIEVING CREAM  

Instaflex

PAIN RELIEF

Formulated with an 

EXCLUSIVE OXYGENATED OIL 

FAST RELIEF FOR ARTHRITIS,

JOINT & MUSCLE PAIN 

Proud Partner of the 

Arthritis

Foundation 

POWEFUL PAIN RELIEF STARTS IN MINUTES,

LASTS FOR HOURS 

Deep Penetrating |  Fast Acting |  Pleasant Smelling |  Non-Greasy 

CLINICALLY STUDIED | DOCTOR DEVELOPED 

Net wt. [2/4] oz ([57/113] g) 

2 oz Tube

2 oz Carton

4 oz Tube

4 oz Carton

INSTAFLEX PAIN RELIEF CREAM 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72779-100
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL12.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
ORANGE OIL (UNII: AKN3KSD11B)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
EUCALYPTUS OIL (UNII: 2R04ONI662)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
LAURETH-7 (UNII: Z95S6G8201)  
CORN OIL (UNII: 8470G57WFM)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYACRYLAMIDE (CROSSLINKED; 0.01-0.2 MOLE PERCENT BISACRYLAMIDE) (UNII: RHA9LWJ494)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72779-100-021 in 1 CARTON01/01/2019
157 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:72779-100-041 in 1 CARTON01/01/2019
2113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2019
Labeler - Adaptive Health, LLC (832215177)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(72779-100)

Revised: 12/2018
Document Id: e7dfe524-438c-45e8-b652-fa625f72bc79
Set id: 911f5021-a851-444e-8c2a-2be4fa94e828
Version: 1
Effective Time: 20181221
 
Adaptive Health, LLC